Material Safety Data Sheet. Blood Glucose Test Strip

Transcription

1 TaiDoc Technology Corporation Material Safety Data Sheet Blood Glucose Test Strip SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product name Product number Product use Blood Glucose Test Strip TD-4352A Glucose dehydrogenase contained dry reagent for in vitro quantitative analysis of human capillary and venous blood glucose. It is intended for use by healthcare professionals. This product is for single use. Manufacturer name TaiDoc Technology Corporation Address 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, Taiwan, R.O.C. Telephone Fax website SECTION 2. COMPOSITION/INFORMATION IN INGREDIENTS Component (within Glucose dehydrogenase (FAD-dependent) the reaction area) Electron shuttle Enzyme protector Non-reactive ingredients All chemical components are mixed and dried under processing. The reaction area contained those chemicals is protected by covering transparent layer on it. Therefore, there is no contact hazard under normal handling. 1/5

2 SECTION 3. HAZARD IDENTIFICATION Rout of entry Hazardous decomposition products Unusual fire, explosion and reactivity hazards Skin-NO Eye-NO Inhalation-NO Ingestion-YES. May cause chocking hazard if swallowed. When exposed to fire, produces normal products of combustion. No special hazards known. SECTION 4. FIRST AID MEASURES Ingestion Medical information If swallowed, seek medical attention. SECTION 5. FIREFIGHTING MEASURES Flash point Flammable limits Upper Lower Extinguishing media Special fire fighting procedure Unusual fire and explosion hazards CO 2, foam, water SECTION 6. ACCIDENTAL RELEASE MEASURES In case of spill or leak There is no spill potential under normal use. If leaked reagents of reaction area happened, dispose the strip into a suitable container and wash contact area with soapy water (ex. hand) 2/5

3 SECTION 7. HANDLING AND STORAGE Safety information Precautions to be taken in Store in secure area handling and storage Keep out of reach of children Storage conditions Store in a cool and dry place (2-32 ). Do not expose to direct light. Must be stored in original container. Handle conditions Handle as directed in the package insert SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Respiratory Protection Skin Eye Protective Gloves Ventilation required. required. required. required. Normal ventilation SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES Characteristic Boiling point Specific Gravity(Water=1) Vapor Pressure (mm Hg) Vapor Density (air=1) Evaporation Rate (Butyl Acetate=1) ph Solubility in Water Appearance Odor Plastic strip plate The ph of dry reagent in reaction well is around White for plastic plate and yellow for reaction well. 3/5

4 SECTION 10. STABILITY AND REACTIVITY Stability Conditions to Avoid Incompatibility Hazardous Decomposition or Byproduct Conditions to Avoid Stable Acids, strong oxidizing agents. Temperature below 2 and above 32. SECTION 11. TOXICOLOGICAL INFORMATION Routes of entry Health hazards Carcinogenicity Medical Conditions Aggravated Ingestion Acute: Choking if swallowed Chronic: SECTION 12. ECOLOGICAL INFORMATION No ecological information available. SECTION 13. DISPOSAL CONSIDERATION Appropriate methods of disposal European Community (EC) consideration Dispose wastes in accordance with Federal, State, and Local requirements. Use appropriate waste codes based on ingredients. SECTION 14. TRANSPORT INFORMATION Transportation precautions Consult applicable regulation when transporting this product. Follow the guidelines listed in the package for proper transportation 4/5

5 SECTION 15. REGULATORY INFORMATION European labeling in accordance with EC Directives Hazard Symbols Safety phrases Keep out of the reach of children Risk Phrases Consult country codes for specific requirements SECTION 16. OTHER INFORMATION TaiDoc Technology Corporation provides the information contained herein in good faith but makes no representation as to its comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary handling of the materials contained in this kit by a properly trained person using this product. TaiDoc Technology Corporation shall not be held liable for any damage resulting from handling or use. This product is for in vitro diagnostics use only. This product is not able to diagnose newborns with diabetes. 5/5